NEW YORK, May 06, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced financial results for the first quarter of 2024.
“The first quarter was marked by strong financial performance for our on-market products which are delivering important and differentiated treatment options for patients living with depression, narcolepsy and obstructive sleep apnea,” said Herriot Tabuteau, MD, CEO of Axsome Therapeutics. “We also significantly advanced our innovative neuroscience pipeline in the quarter. We announced positive Phase 3 results for AXS-12 in narcolepsy, a major step toward making this new medicine available to patients living with this debilitating condition, and we launched two pivotal trials of solriamfetol in major depressive disorder and binge eating disorder. In the coming months we look forward to resubmitting our NDA for AXS-07 in migraine, and to submitting our NDA for AXS-14 in fibromyalgia. Our Phase 3 ADVANCE-2 trial of AXS-05 in Alzheimer’s disease agitation remains on track for completion in the second half of 2024. Further, we added to the robustness of this clinical development program with the initiation of the ACCORD-2 study of AXS-05 in Alzheimer’s disease agitation, a Phase 3 randomized withdrawal trial, for which we expect to complete enrollment mid-year 2024.”
First Quarter 2024 Financial Highlights
Financial Guidance
·Axsome believes that its current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan.
Commercial Highlights
Auvelity
Sunosi
Development Pipeline
Axsome is advancing an industry-leading neuroscience portfolio encompassing five innovative, late-stage, patent-protected product candidates for 10 serious psychiatric and neurologic conditions, which affect more than 150 million people in the U.S. alone. Recent and anticipated progress for key pipeline programs is summarized below.
AXS-05
AXS-05 (dextromethorphan-bupropion) is Axsome’s novel, oral, investigational NMDA receptor antagonist and sigma-1 agonist being developed for Alzheimer’s disease (AD) agitation and smoking cessation. AXS-05 has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for AD agitation.
AXS-07
AXS-07 (MoSEIC™ meloxicam-rizatriptan) is Axsome’s novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine for the acute treatment of migraine.
AXS-12
AXS-12 (reboxetine) is Axsome’s novel, oral, potent, investigational highly selective norepinephrine reuptake inhibitor and cortical dopamine modulator for the treatment of narcolepsy. AXS-12 has been granted FDA Orphan Drug designation for the treatment of narcolepsy.
AXS-14
AXS-14 (esreboxetine) is Axsome’s novel, oral, potent, highly selective investigational norepinephrine reuptake inhibitor for the management of fibromyalgia. Esreboxetine, the SS-enantiomer of reboxetine, is more potent and selective than racemic reboxetine.
Solriamfetol
Solriamfetol is Axsome’s dopamine and norepinephrine reuptake inhibitor and TAAR1 agonist in development for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD), binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD).
Anticipated Milestones
Conference Call Information
Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss first quarter 2024 financial results as well as to provide a corporate update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic). The live webcast can be accessed on the "Webcasts & Presentations" page of the "Investors" section of the Company’s website at axsome.com. A replay of the webcast will be available for approximately 30 days following the live event.
About Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the continued commercial success of our Sunosi® and Auvelity® products and the success of our efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our product candidates, including statements regarding the timing of any NDA submission; whether issues identified by FDA in the complete response letter may impact the potential approvability of the Company’s NDA for AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to our special protocol assessment for the MOMENTUM clinical trial; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the continued commercialization of Sunosi and Auvelity and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; unforeseen circumstances or other disruptions to normal business operations arising from or related to geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.
| Axsome Therapeutics, Inc. Selected Consolidated Financial Data | ||||||||
| Axsome Therapeutics, Inc. Consolidated Balance Sheets (In thousands, except share and per share amounts) | ||||||||
| March 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 331,441 | $ | 386,193 | ||||
| Accounts receivables, net | 101,434 | 94,820 | ||||||
| Inventories, net | 15,583 | 15,135 | ||||||
| Prepaid and other current assets | 12,032 | 8,115 | ||||||
| Total current assets | 460,490 | 504,263 | ||||||
| Equipment, net | 812 | 846 | ||||||
| Right-of-use asset - operating lease | 6,411 | 6,772 | ||||||
| Goodwill | 12,042 | 12,042 | ||||||
| Intangible asset, net | 51,697 | 53,286 | ||||||
| Non-current inventory and other assets | 14,276 | 11,027 | ||||||
| Total assets | $ | 545,728 | $ | 588,236 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 53,791 | $ | 40,679 | ||||
| Accrued expenses and other current liabilities | 82,716 | 90,501 | ||||||
| Operating lease liability, current portion | 1,153 | 1,267 | ||||||
| Contingent consideration, current | 6,388 | 6,407 | ||||||
| Total current liabilities | 144,048 | 138,854 | ||||||
| Contingent consideration, non-current | 70,000 | 73,300 | ||||||
| Loan payable, long-term | 178,689 | 178,070 | ||||||
| Operating lease liability, long-term | 7,258 | 7,035 | ||||||
| Finance lease liability, long-term | 1,697 | — | ||||||
| Total liabilities | 401,692 | 397,259 | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $0.0001 par value per share (10,000,000 shares authorized, none issued and outstanding) | — | — | ||||||
| Common stock, $0.0001 par value per share (150,000,000 shares authorized, 47,464,575 and 47,351,363 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively) | 5 | 5 | ||||||
| Additional paid-in capital | 1,047,959 | 1,026,543 | ||||||
| Accumulated deficit | (903,928 | ) | (835,571 | ) | ||||
| Total stockholders’ equity | 144,036 | 190,977 | ||||||
| Total liabilities and stockholders’ equity | $ | 545,728 | $ | 588,236 | ||||
| Axsome Therapeutics, Inc. Consolidated Statements of Operations (Unaudited) (In thousands, except share and per share amounts) | ||||||||
| Three months ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenues: | ||||||||
| Product sales, net | $ | 74,096 | $ | 28,569 | ||||
| License revenue | — | 65,735 | ||||||
| Royalty revenue | 903 | 272 | ||||||
| Total revenues | 74,999 | 94,576 | ||||||
| Operating expenses: | ||||||||
| Cost of revenue (excluding amortization and depreciation) | 6,297 | 7,556 | ||||||
| Research and development | 36,830 | 17,793 | ||||||
| Selling, general and administrative | 98,970 | 74,191 | ||||||
| Gain in fair value of contingent consideration | (1,412 | ) | (162 | ) | ||||
| Intangible asset amortization | 1,589 | 1,572 | ||||||
| Total operating expenses | 142,274 | 100,950 | ||||||
| Loss from operations | (67,275 | ) | (6,374 | ) | ||||
| Interest expense, net | (1,082 | ) | (2,264 | ) | ||||
| Loss before income taxes | (68,357 | ) | (8,638 | ) | ||||
| Income tax expense | — | (2,580 | ) | |||||
| Net loss | $ | (68,357 | ) | $ | (11,218 | ) | ||
| Net loss per common share, basic and diluted | $ | (1.44 | ) | $ | (0.26 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 47,393,563 | 43,523,631 | ||||||
Axsome Contacts:
Investors:
Mark Jacobson
Chief Operating Officer
Axsome Therapeutics, Inc.
One World Trade Center, 22nd Floor
New York, NY 10007
Tel: 212-332-3243
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
www.axsome.com
Media:
Darren Opland
Director, Corporate Communications
Axsome Therapeutics, Inc.
One World Trade Center, 22nd Floor
New York, NY 10007
Tel: 929-837-1065
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
www.axsome.com
| Last Trade: | US$104.46 |
| Daily Change: | -0.01 -0.01 |
| Daily Volume: | 327,539 |
| Market Cap: | US$5.060B |
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